Last week, Science-ish published a letter to the Honourable Leona Aglukkaq, Canada’s Federal Minister of Health, in response to an announcement she made about the government’s intention to create “a web-based list” of clinical trials for Canadian patients.

On the surface this sounded like a great idea—a way to improve patient access to and knowledge of clinical trials happening in this country. But like most things, the reality is a little more complicated. As Science-ish explained, such a listing hasn’t empowered patients in other jurisdictions, and it probably won’t here. It’s completely out of step with the evidence and it ignores on-goingconversations that have been happening for about a decade regarding clinical trials registries and open datahere, and around the world.

Science-ish has been steadfastly working on obtaining a comment from the minister about the plan. After numerous phone calls and emails, the minister’s press secretary, Cailin Rodgers, agreed to look into the issue. She did not respond by deadline.

For now, leading Canadian researchers who look at clinical trials and nerdy things like pharmaceutical policy, drug regulation, and evidence-based medicine, have weighed in with their own letters to the minister. They are wise. We can all learn from them.

Dr. Gordon Guyatt (MD, O.C., FRCPC), distinguished professor in the departments of medicine and clinical epidemiology and biostatistics, McMaster University

Canadians suffering from illness, and their health-care providers, are entitled to access all of the best evidence regarding the treatment options open to them. It is unethical that Canadians suffering from serious illness—indeed from any illness at all—may be presented with a biased sample of the evidence that misleads them about the benefits and harms of treatments they are considering.

Yet, this is the situation that the Canadian government currently permits. There is an urgent need for a government initiative that deals with this unacceptable state of affairs. That the government would announce, with apparent fanfare, a “web-based list” of clinical trials without any attempt to prevent industry from withholding trial results is deeply and bitterly ironic. Surely we can do better—much better—in ensuring Canadians access to the information they need to make rational decisions regarding optimal treatment.

Matthew Herder (L.L.B., L.L.M., J.S.M.), assistant professor in the school of medicine, Dalhousie University

Transparency is important in the context of regulating pharmaceutical drugs for many reasons, from preventing harms to patients and respecting research participants’ contributions to research, to improving regulatory science and increasing innovation. It is not clear whether the Minister of Health’s decision to create a web-based list of authorized Canadian clinical trials will service any of these goals.

This is not to say that institutionalizing transparency is easy stuff. As commentators have pointed out transparency is not a truism. Yet governments, courts, media, and critics alike tend to frame it as a self-evident principle, typically quoting Louis Brandeis’ famous line “sunlight is said to be the best of disinfectants.”

Operationalizing transparency requires answers to a number of substantive questions, including: Why should something be transparent? What exactly should be transparent? When should something be transparent? What should trigger transparency? What are the institutional mechanisms of transparency? Who are the audiences of transparency? What are the consequences of transparency, or of failing to comply with transparency requirements? What are the tradeoffs potentially associated with transparency?

These are the very questions that policy-makers and drug regulators in other jurisdictions have grappled with or continue to tackle. And that’s precisely why the minister’s announcement is so disappointing. It demonstrated little interest in grappling with these critical policy questions, and no attention to what policy-makers are doing elsewhere.

It’s time Canada moved beyond paying lip service to transparency, and got serious about figuring out what that entails in the context of regulating medicines.

Dr. Michael Law (PhD), assistant professor in the school of population and public health, UBC

Every year, thousands of Canadians give their time, and sometimes their health, to participate in clinical trials of new medicines. I think they do so in the belief that they might personally benefit from a new therapy, but also because it feels important for them to be part of creating new scientific knowledge.

However, we know that the results from many clinical studies are never published. This leaves the knowledge that was created hidden from the public, from their physicians, and from regulators that make decisions about the safety and efficacy of medicines.

I believe it is critical that when Canada introduces our clinical trial registry, we need to use this as an opportunity to not only enhance the ability of patients to find trials, but make it mandatory that those conducting trials in Canada report the results in the registry as well. This will increase transparency in science, and enhance our knowledge about the prescription drugs that millions of Canadians use to treat dozens of important health conditions.

Let’s not just follow other countries in creating a registry; let’s become world leaders in the transparency with which we allow clinical trials to be conducted with Canadian participants.

Dr. Joel Lexchin (MD), professor in the school of health policy and management at York University and emergency department physician at University Health Network

The refusal of Health Minister Leona Aglukkaq and Health Canada to take any meaningful action about improving transparency about clinical trials is disappointing but not surprising.

Health Canada has been studying whether or not to require mandatory clinical trial registration since June 2005—and still has apparently not reached any decision.

The minister and her department refuse to release information about the clinical trials that drug companies submit citing commercial confidentiality as the reason. Does confidentiality trump patient safety?

Apparently Health Canada thinks so since there are numerous instances where releasing the information that Health Canada possesses would have led to significant improvements in how drugs were used. Health Canada puts about four times the money and personnel into approving new drugs as it does into monitoring the safety of drugs already on the market. Public health versus private profits – it’s clear where Health Canada and Leona Aglukkaq’s priorities are.

Science-ish is a joint project of Maclean’s, the Medical Post and the McMaster Health Forum. Julia Belluz is the associate editor at the Medical Post. Got a tip? Seen something that’s Science-ish? Message her at julia.belluz@medicalpost.rogers.com or on Twitter @juliaoftoronto

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About this author

Julia Belluz is a National Magazine Award-winning journalist covering health care and policy. A Knight Science Journalism Fellow at MIT, she writes the blog/column ‘Science-ish' for Maclean's and the Medical Post about the evidence behind the health headlines.

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I can understand drug companies’ reluctance to release raw data, because they spent a lot of money obtaining it. I think the summary data pretty much falls into the same logic as breathalyzers — there’s definitely a violation of privacy, but the public good requires it, ie, I need to live more than you need your privacy. I’d probably be content with mandatory release of summary information, with raw data after a number of years or earlier if requested by a judge in a process like a search warrant. While I think full disclosure should be possible, any violation of privacy rights should be overseen by the judicial system, not politicians.

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